Future Leaders Program: Testing a Youth Leadership, Engagement, and Mindfulness Program

NCT06736522 | Recruiting DMC

• 2 other identifiers: 7018E4UH3AT012530
• Study Type: interventional
• Target: 504
• Locations: 1 country
• Sites: 2

Brief Summary

The current study tests the feasibility and effectiveness of a youth intervention designed to provide meaningful leadership opportunities through the acquisition of leadership skills as well as mindfulness practice, LEAP: Leadership, Engagement, and youth Action Program with Mindfulness. The goal of this project is to determine whether the Leadership, Engagement, and youth Action Program with Mindfulness (LEAP) curriculum, which was developed with youth, is a feasible and effective intervention for fostering leadership and well-being. The investigators seek to understand whether LEAP can support wellbeing for youth as a strategy to increase youth mental, emotional, and behavioral (MEB) health.

Conditions

Adolescent Behavior Problem; Mental Health Wellness 1

Keywords

mindfulness; youth leadership; youth wellbeing

Outcome Measures

Primary Outcomes (3)

• Engagement, Perseverance, Optimism, Connectedness, and Happiness (EPOCH; Kern et al., 2016) measure of adolescent wellbeing

  20-item, 5-point scale measuring five positive characteristics that support higher levels of wellbeing: Engagement, Perseverance, Optimism, Connectedness, and Happiness. The scale range is 1-5, higher scores indicate better wellbeing.

  Baseline, 2-3 months, 6 months, 9 months

• Strengths and Difficulties Questionnaire (SDQ; Goodman, 2001)

  25 item multiple choice questionnaire that measures internalizing and externalizing problems and prosocial behavior (emotional, conduct, hyperactivity-inattention, peer, prosocial). The scale range is 0-40, higher scores indicate worse difficulties.

  Baseline, 2-3 months, 6 months, 9 months

• Self-Rated Health 12-item Short-Form Survey (SF-12; Ware et al., 1996)

  12 item 5-point survey measuring general health, asking about overall health self-rating, ability to do daily activities, energy levels, and physical and emotional limitations. The scale range is 0-100, higher scores indicate better health.

  Baseline, 2-3 months, 6 months, 9 months

Secondary Outcomes (2)

• Student Career Construction Inventory (Savickas, 2018)

  Baseline, 2-3 months, 6 months, 9 months

• Vocational Skills Self-Efficacy (VSSE; McWhirter et al., 2000)

  Baseline, 2-3 months, 6 months, 9 months

Study Arms (2)

Leadership, Engagement, and youth Action Program with Mindfulness

EXPERIMENTAL

The Leadership, Engagement, and youth Action Program with Mindfulness intervention (LEAP) consists of 14 sessions focused on youth leadership and mindfulness.

Behavioral: Leadership, Engagement, and youth Action Program with Mindfulness

EnvisionIT

ACTIVE COMPARATOR

EnvisionIT is a college and career-readiness program designed for students in grades 6-12. The EnvisionIT program will be delivered over 14 sessions, and focus on skills and career/college readiness.

Behavioral: EnvisionIT

Interventions

Leadership, Engagement, and youth Action Program with Mindfulness BEHAVIORAL

The Leadership, Engagement, and youth Action Program with Mindfulness intervention (LEAP) was designed and co-created with youth to improve youth well-being by enhancing leadership opportunities and by developing mindfulness in day-to-day life. LEAP seeks to foster these improvements in youth and to increase youth mental, emotional, and behavioral health. Youth voice is incorporated into the intervention, with facilitators leading the first 7 sessions, and youth leading the remainder.

Also known as: LEAP

Leadership, Engagement, and youth Action Program with Mindfulness

EnvisionIT BEHAVIORAL

Participants in this arm will receive 14 sessions of EnvisionIT training, focused on preparing students with essential skills including digital literacy through competency in information technology, financial literacy, English language arts skills, and college and career readiness. All sessions will be delivered by facilitators trained in EnvisionIT.

EnvisionIT

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adolescents ages 14 and older in grades 9-12 during the Fall/Winter or in grades 9-11 during the Spring
• Enrolled in a partner site in Massachusetts or Illinois
• Adolescents are only included with parent consent and youth assent if they are under the age of 18. Adolescents at least 18 years old can provide consent.

You may not qualify if:

• They participated in the pilot phase (UG3)
• They cannot commit to participation in the full study (e.g., attendance at all intervention sessions)
• They are not in grades 9-12 at a partner site
• Parent/guardian has a preferred consent language other than English or Spanish.

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (2)

University of Illinois, Chicago

Chicago, Illinois, 60608, United States

NOT YET RECRUITING

METCO

Boston, Massachusetts, 02119, United States

RECRUITING

Related Publications (1)

• Alegria M, Alvarez K, NeMoyer A, Zhen-Duan J, Marsico C, O'Malley IS, Mukthineni R, Porteny T, Herrera CN, Najarro Cermeno J, Kingston K, Sisay E, Trickett E. Development of a Youth Civic Engagement Program: Process and Pilot Testing with a Youth-Partnered Research Team. Am J Community Psychol. 2022 Mar;69(1-2):86-99. doi: 10.1002/ajcp.12548. Epub 2021 Aug 4.

  PMID: 34350588 BACKGROUND

MeSH Terms

Interventions

Leadership; Mindfulness

Intervention Hierarchy (Ancestors)

Personnel Management; Organization and Administration; Health Services Administration; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Mario Cruz-Gonzalez, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Greif Green, PhD

CONTACT

617-353-3253; jggreen@bu.edu

Mario Cruz-Gonzalez, PhD

CONTACT

617-513-8762; mcruzgonzalez@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors will be masked to study condition.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Individually Randomized Group Treatment Trial Design

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 16, 2024
• Study Start: December 16, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be shared after findings for primary outcomes are published. Time frame for sharing will be based on requests, based on recommendations from the funding agency.
• Access Criteria: Determinations will be made on a case-by-case basis of what type of data can be shared while maintaining confidentiality of respondents. Any data shared will be de-identified and will follow established systems for security in data use.

Locations

US (2)